SpermQT Prospective Observational Trial

The goal of the study is to validate the ability of the Epigenetic Sperm Quality Test (SpermQT) to assess a man's sperm quality and corresponding success of infertility treatments.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Male Infertility Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Male Fertility and Sexual Medicine Specialists, San Diego, California, United States

About this study

This prospective study will consist of analyzing a man's semen sample to determine the patient's SpermQT score and following the success of each fertility treatment to produce a pregnancy and live birth. Physicians and patients will be blinded to SpermQT results.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The subjects have been recommended to pursue IUI, or they have recently completed an IUI (regardless of outcome)
Male partner is under 45 years of age
Female partner is under 38 years of age
The total motile sperm count from the raw semen analysis must be greater than or equal to 10 million

Exclusion criteria

The female or male partner have a BMI equal to or greater than 40
The male partner has undergone male testosterone replacement therapy in the last 6 months
Either the female or male partner have a history of recurrent pregnancy loss, defined as 2 or more consecutive clinical/ultrasound pregnancy losses
There are any known factors contributing to female factor infertility, such as but not limited to:
Severe Endometriosis (stage 3 or higher, endometrioma on ovaries)
Multiple uterine fibroids 5cm or larger
Severe Asherman's Syndrome
Severe Mullerian anomaly
Lack of tubal patency in at least one fallopian tubes

Treatment and study plan

Primary outcomes

Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of intrauterine insemination (IUI)

Time frame: 6 months

Number of patients that have and have not achieved pregnancy during rounds 1 and 2 of IUI in each bracket of SpermQT score (Poor, Normal, and Excellent)

Secondary outcomes

Number of patients that have and have not achieved pregnancy during subsequent rounds of intrauterine insemination (IUI) and in vitro fertilization (IVF)

Time frame: 18 months

Number of patients that have and have not achieved pregnancy during subsequent rounds of IUI and with IVF in each bracket of SpermQT score (Poor, Normal, and Excellent)
Number of patients that have and have not achieved a live birth

Time frame: 18 months

Number of patients that have and have not achieved a live birth in each bracket of SpermQT score (Poor, Normal, and Excellent)

Sponsors and collaborators

Lead sponsor

Inherent Biosciences

Industry

Collaborators

Boston IVF
Brigham Young University
Inception Fertility Research Institute, LLC
Male Fertility and Sexual Medicine Specialists
Shady Grove Fertility
University of Washington
Yale University

Registry information

Acronym: SPOT

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Aug 1, 2023
Registry last updated: Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting